PHARMACY

Federal court overturns Caraco patent litigation case conclusion

BY Alaric DeArment

DETROIT A federal court has remanded a patent litigation case surrounding a painkiller drug to a lower court, generic drug maker Caraco Pharmaceutical Labs announced last week, delivering a victory to the branded drug’s manufacturer.

Caraco said a U.S. Court of Appeals for the Federal Circuit had remanded the case, filed by Johnson & Johnson subsidiary Ortho McNeil regarding the drug Ultracet (acetominophen and tramadol hydrochloride), while finding that a portion of Ortho McNeil’s patent on the drug was invalid, though Caraco did not specify what portion that was.

Caraco and other companies had been selling generic versions of Ultracet for several years, though J&J had been seeking to get them pulled from the market. J&J’s patent on the drug expires in August 2011, according to the Food and Drug Administration.

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Japanese drug maker permitted to start clinical trials of diabetes drug

BY Alaric DeArment

OSAKA, Japan The Food and Drug Administration has given a Japanese drug maker permission to start clinical trials of a diabetes drug.

Takeda Pharmaceutical Co. announced Friday that the FDA had agreed to the design of a study to examine the effects on cardiovascular safety of the Type 2 diabetes drug alogliptin.

The study will begin next month and end in December 2014, enrolling about 5,400 patients at 1,000 sites in the United States, Europe and Asia.

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FDA rejects application for new epilepsy drug

BY Alaric DeArment

TITUSVILLE, N.J. A drug maker’s regulatory approval application for a new epilepsy drug has been rejected.

Johnson & Johnson announced last week that the Food and Drug Administration had delivered it a complete response letter regarding the drug Comfyde (carisbamate). A complete response letter means that the agency requires additional clinical data before it will approve a new drug or a new use for an existing drug.

J&J filed its application in October, seeking approval for the drug as a treatment for partial onset seizures in patients aged 16 and older.

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